Therapeutic Innovation & Regulatory Science

Article	Citations
Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study	62
Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States	54
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry	42
The Ethics of the “Right-to-Try” Movement in an Era of Regulatory Flux	40
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs	38
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry	35
Anti-lung Cancer Marine Compounds: A Review	34
Developing a More Tailored Approach to Patient and Public Involvement with Children and Families in Pediatric Clinical Research: Lessons Learned	33
The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data	32
Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review	30
Experimental Study of the Promotional Implications of Proprietary Prescription Drug Names	29
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory Trial	28
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan’s Participation and Small/Medium Companies-Sponsored Trials	26
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States	26
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union	24
A Generalization of the Two Trials Paradigm	22
Pharmacometrics: The Already-Present Future of Precision Pharmacology	22
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices	22
Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data	22
Correction: Review of Recent Pharmacoepidemiologic Post-Market Safety Studies Through the Lens of the Estimand Framework	20
Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance	19
New Estimates on the Cost of a Delay Day in Drug Development	18
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System	18
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases	17
Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries	17

The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis	17
Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia	16
A Five-Year Analysis of Market Share and Sales Growth for Original Drugs after Patent Expiration in Korea	16
Estimand Endpoints for Longitudinal Measures of Continuous Disease Progression with an Alzheimer’s Disease Example	16
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today	16
Decentralized Clinical Trials in the Development of Drugs and Biological Products	16
Real World Evidence in Medical Cannabis Research	16
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model	15
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations	15
Benchmarking Protocol Deviations and Their Variation by Major Disease Categories	15
Pharmaceutical Company’s Choices of Indication for the First Clinical Projects in Oncological Drug Development in the United States	14
Tracking a Medicine’s Regulatory Risk Management Commitments Provides Better Transparency and Oversight	14
Leveraging Patient Preference Information in Medical Device Clinical Trial Design	14
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data	13
Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study	13
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology	13
Correction: A Global Industry Survey on Post-Approval Change Management and Use of Reliance	12
Japanese Regulatory Considerations for Interoperability of Medical Devices	12
Overdosage Section in US and EU Labeling	12
Correction: Consumer Understanding of Prescription Drug Indications in Direct-to-Consumer Television Advertisements	12
Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept Study	12
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials	11
Training New DMC Members: A Call to Action	11
Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts	11
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study	11
Performance Evaluation of Interim Analysis in Bioequivalence Studies	11
Applying Aggregate Statistical Analyses to Safety Monitoring of Ongoing Clinical Studies, Issues, and Opportunities in a Test Case	11
Digital Tools—Regulatory Considerations for Application in Clinical Trials	10
Trends in FDA Data Integrity Enforcement Before and After the COVID-19 Pandemic: An Analysis of 1766 Warning Letters (2016–2023)	10
Unmet Therapeutic Needs of Non-Ambulatory Patients with Duchenne Muscular Dystrophy: A Mixed-Method Analysis	10
Transforming Objective Participatory Patient Advocacy	9
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals	9
Risk Management in Drug-Device Combination Product Development	9
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials	9
Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data	9
Focusing on First Cycle Approval in ANDA Submission: Understanding Common Deficiencies & Case Study Insights	9
Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended	9
Correction to: Performance Evaluation of Interim Analysis in Bioequivalence Studies	9
Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private–Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Gen	8
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies	8
Risk-Based Quality Management: A Case for Centralized Monitoring	8
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery	8
Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan	8
Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data	8
Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan	8
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry	8
A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies	8
Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies	8
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy	8
AI/ML in Precision Medicine: A Look Beyond the Hype	8

Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen	8
Adaptive Design with Bayesian Informed Interim Decisions: Application To a Randomized Trial of Mechanical Circulatory Support	7
Cancer Clinical Trial Patients’ Perceptions of Reporting Adverse Events Via an Electronic Platform	7
Statistical Analysis for Rating Scale in Clinical Trials	7
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies	7
Consideration for Assessing Data/Models/Tools Expiration Supporting Drug Development and Clinical Decision Making	7
The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application	7
The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data	7
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval	7
Adoption Maturity Model for Risk-based Quality Management (RBQM) in Clinical Trials	7
Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent Tails	7
Opportunities in Development of Patient-Centric and Decentralized Clinical Trials: Insights from Patients and Healthcare Professionals in Respiratory and Rare Diseases	7
Advancing Oncology Drug Development in the US: The Interplay between Innovations and Regulatory Science	7
Health Equity in Pediatric Drug Development: Translating Aspiration into Operation	7
Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)	7
Using Large Language Models for Advanced and Flexible Labelling of Protocol Deviations in Clinical Development	7
Improving Informed Consent for English and Spanish Speakers in Clinical Trials	7
Assessing the Risk of Decrease in Kidney Function in Patients Prescribed Direct-Acting Antivirals for Hepatitis C Utilizing the MID-NET® Medical Information Database Network in Japan	6
Joint Task Force Core Competency Framework Adoption Process at a National Level: A Survey of Ukrainian-Based Clinical Research Professionals	6
A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in Japan	6
A Global Industry Survey on Post-Approval Change Management and Use of Reliance	6
Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation	6
Bayesian Clinical Trials	6
Provision of Drug Information Using Database Surveys-Enhancing Clinical Information for Patients with Specific Backgrounds	6
The Data Monitoring Experience in Empagliflozin Randomized Clinical Trials Between 2011 and 2024	6
The Use of Unmanned Aerial Vehicles (UAV) on Delivering Biological Samples for COVID-19 and Tuberculosis Diagnosis: A Scoping Review	6
Patient Experience Data (PED) in 2019–2023 US FDA NME Drug Approvals: Analysis and Recommendations	6
Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making	6
Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection	6
Considerations and Approaches to Establishing Estimates of Meaningful Change for Digital Endpoints as Drug Development Tools	6
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	6
Application of 3D Whole-Brain Texture Analysis and the Feature Selection Method Based on within-Class Scatter in the Classification and Diagnosis of Alzheimer’s Disease	6
Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities	6
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways	6
Beyond Juul: The New Face of Underage Nicotine Addiction - A Survey of College Students	5
Pharmacometrics-Enhanced Bayesian Borrowing for Pediatric Extrapolation – A Case Study of the DINAMO Trial	5
Application of Meta-analysis to Evaluate Relationships Among ARIA-E Rate, Amyloid Reduction Rate, and Clinical Cognitive Response in Amyloid Therapeutic Clinical Trials for Early Alzheimer’s Disease	5
Measuring Patient Participation Burden in Clinical Outcome Assessments for Clinical Trials	5
Hypocalcemia Event Associated with Denosumab: A Real-World Study from FDA Adverse Event Reporting System (FAERS) Database	5
How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline	5
Untangling the Biosimilars Interchangeability Puzzle: A Provocative Dive into Concepts and Terminology, and Developing a Strategy to Minimize Uncertainties from Interchangeability	5
Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events	5
Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020	5
Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations	5
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage	5
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team	5
Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups	5
Machine Learning in Tuberculosis Research: A Global Bibliometric Analysis of Diagnostic, Prognostic, and Drug Discovery Trends	5
Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil	5
Statistical Considerations and Challenges with Time-to-Event Analyses for Composite Endpoints in Clinical Trials	4
Digital Health Technologies in Pediatric Trials	4
Correction: Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions	4
The Beginning of a “Regulatory Renaissance”: Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support	4
Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward	4
Descriptions of Abnormal Kidney Function in Contraindications: A Cross-Sectional Analysis of Japanese Prescription Drug Labeling Under the New Format	4
Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?	4
Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ Post-Market Surveillance	4
Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in Oncology	4
Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World Data	4
A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission	4
Leveraging Multi-National Observational Study in Post-Marketing Safety Assessment: Challenges and Strategies	4
Mutagenic Azido Impurities in Drug Substances: A Perspective	4
Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials	4
Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence	4
New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance	4
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency	4
Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials	3
Developing a Set of AI Ethics Principles to Shape Ethical Behavior in Drug Development	3
A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols	3
An Evaluation of Time Spent Completing Electronically Collected Patient-Reported Outcomes in Clinical Trials	3
Basic Considerations for the Consistency Evaluation Based on ICH E17 Guideline	3
A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators	3
Insights on Clinical Development of Cell and Gene Therapy for Rare Diseases—by DahShu Innovative Design Scientific Working Group (IDSWG)	3
Interim Clinical Trial Data: Who Can See What, and When?	3
Incretin Dominance and Emerging Mechanisms in Obesity Pharmacotherapy: Insights from 275 Registered Clinical Trials (2019–2024)	3
Characterization of Japanese Risk Management Plans after 10 Years of Implementation: 2013–2023	3
Correction: The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals	3
The Term ‘Deselect’ is Ambiguous as Used in Research Studies to Support Prescription to Nonprescription Switches	3
The Predictive Individual Effect for Survival Data	3
Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials	3

Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia	3
Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders	3
The Path To Tarlatamab Approval: Leveraging Innovative Strategies and Global Regulatory Pathways	3
Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners	3
Extrapolation as a Default Strategy in Pediatric Drug Development	3
EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results	3
Non-monotone Exponential Time (NEXT) Model for the Longitudinal Trend of a Continuous Outcome in Clinical Trials	3
Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa	3
How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions	3
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement	3
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials	3
US FDA’s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapie	3
Expanding Pharmaceutical Access Via Over the Counter Drugs	3
Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for Validation	3
Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers	3
Detection, Monitoring, and Mitigation of Drug-Induced Nephrotoxicity: A Pragmatic Approach	3
Advancing AI Ethics Frameworks in Drug Development: Global Applicability, Practical Challenges, and Dynamic Governance	3
Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol Data	3
Better Medicines for Children: Lessons Learnt and Share Learnings at the EFGCP Annual Paediatric Conferences	3
Semantic Search of FDA Guidance Documents Using Generative AI	2
Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology	2
Solution Oligonucleotide APIs: Regulatory Considerations	2
Comparison Between Simultaneous and Sequential Utilization of Safety and Efficacy for Optimal Dose Determination in Bayesian Model-Assisted Designs	2
The Inflation Reduction Act and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials	2
A Flexible Ensemble Learning Method for Survival Extrapolation	2
Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action	2
The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study	2
Quantifying Site Burden to Optimize Protocol Performance	2
Publisher Correction: Survey Result for E-labeling Initiatives in Asia	2
Call for Papers: The Inflation Reduction Act and Its Impact on Innovation, Access, and Affordability	2
The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History	2
Optimal Sample Size for Use in Neonatal Pharmacokinetic Studies	2
Quantitative Investigation on Exposure to Potentially Harmful Excipients by Injection Drug Administration in Children Under 2 Years of Age and Analysis of Association with Adverse Events: A Single-Cen	2
Evolution of Phase II Oncology Trial Design: from Single Arm to Master Protocol	2
The Medical Information Scientific Process: Define, Research, Evaluate, Synthesize, and Share (DRESS)	2
Correction: Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefi	2
Survey Result for E-labeling Initiatives in Asia	2
Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device	2
Important Considerations for Signal Detection and Evaluation	2
Review of Recent Pharmacoepidemiologic Post-Market Safety Studies Through the Lens of the Estimand Framework	2
Patient Preferences Regarding Surgical Treatment Methods for Symptomatic Uterine Fibroids	2
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals	2
Changes in Companion Diagnostic Labelling: Implementation of FDA’s April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups	2
A Composite Endpoint for Acceptability Evaluation of Oral Drug Formulations in the Pediatric Population	2
Evaluation of United Kingdom (UK)—Windsor Framework and Comparison Against European Union (EU) Regulations for Medicines Regulation	2
Factors Affecting Success of New Drug Clinical Trials	2
Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China	2
Evaluation of FDA Labeling Changes Related to PREA Safety–Waivers	2
Changes in Medication Use During Pregnancy for Women with Chronic Conditions: An Analysis of Claims Data	2
Building from Patient Experiences to Deliver Patient-Focused Healthcare Systems in Collaboration with Patients: A Call to Action	2
Incorporating Patient Input into the Target Product Profile	2
Pediatric Market Access: A Qualitative Study	2
A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry	2
Analysis of Phase I Clinical Trial Design of Anti-Cancer Agents	2
Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video	2
New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics	2
Review of the European Union Clinical Trials Regulation: Key Early Learnings from the United Kingdom Drug Information Association Medical Writing Committee	2
Public Perspectives on Direct-to-Consumer Testing Oversight	2
Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information	2
Analysis of Off-target Effects and Risk Assessment Leading from Preclinical to Clinical Trials of Gene-edited Therapeutic Products	2
Application of Bayesian Borrowing Methods in Clinical Trials for Children with Type II Diabetes Mellitus	2
An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space	2
Publisher Correction: Leveraging Multi-National Observational Study in Post-Marketing Safety Assessment: Challenges and Strategies	2
An Extended Framework of Multiple Testing in Group Sequential Design	2
Correction: Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method	2
Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach	2
The Role of Master Protocols in Pediatric Drug Development	2
Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection	2
Examining Endpoint Concordance in Clinical Trials and Real-World Clinical Practice to Advance Real-World Evidence Utilization	2
Development of a Drug Safety Signal Detection Reference Set Using Japanese Safety Information	2
Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials	2
Draft Guideline for Industry to Manage Drug Shortages in Japan	1
Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine	1
Delivering Digital Health Solutions that Patients Need: A Call to Action	1
Data Monitoring Committee Reports: Telling the Data’s Story	1
The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals	1
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines	1
Inside the Mind of the DMC: A Review of Principles and Issues with Case Studies	1
Influence Diagnostics of a Region of Interest in Multi-regional Clinical Trials	1
Randomized Controlled Trial Data for New Drug Application for Rare Diseases in Japan	1
Implementation of Regulation (EU) No 536/2014 as a Non-commercial Sponsor: An Internal Survey and a Descriptive Analysis of Timelines	1
The Data Monitoring Committee: A Collective or a Collection?	1
Strategic Drivers Behind Early Withdrawal of Orphan Designations in the EU: A Retrospective Analysis (2000–2024)	1
Beyond REMS & PDMPs: A Proposed Framework for Next-Generation Opioid Regulation	1
Estimation of the Under-Reporting of Suspected Serious Adverse Drug Reactions in Japan Using An Interrupted Time Series Analysis	1
Post-approval Activities Providing Data on the Safety of Medication Use During Pregnancy and Lactation—A TransCelerate Perspective	1
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019	1
On the Application of Artificial Intelligence/Machine Learning (AI/ML) in Late-Stage Clinical Development	1
A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing Surveillance	1
Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act	1
Leveraging Real-World Data in Safety Signal Assessment	1
Adaptation of the WOMAC for Use in a Patient Preference Study	1
Valuation and Returns of Drug Development Companies: Lessons for Bioentrepreneurs and Investors	1
Incorporating Patient Needs and Perspectives in Additional Risk Minimization Measures and Other Pharmacovigilance Deliverables - A Framework and Implementation Roadmap	1
The Adoption and Use of Artificial Intelligence and Machine Learning in Clinical Development	1